BD Introsyte 384040Recalls & reported problems
Becton, Dickinson And Company · INTRODUCER INTROSYTE 4F 3.2CM · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 50382903840408), received between Jun 24, 2019 and Jun 24, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Device Contamination with Chemical or Other Material1
- Leak/Splash1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 24, 2019Leak/Splash; Device Contamination with Chemical or Other Material; Leak/Splash; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT "APPROXIMATELY 3CM" OF THE BD INTROSYTE¿ PRECISION INTRODUCER WAS FOUND BROKEN AFTER OPENING UP THE MATERIAL DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "WHEN OPENING THE MATERIAL, IT WAS NOTICED THAT IT WAS APPROXIMATELY 3CM BROKEN."
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8728220 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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